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CATEGORY: DOCUMENTATION
Technical Documentation
The comprehensive set of documents demonstrating that a medical device meets applicable regulatory requirements. Under EU MDR, technical documentation must include device description, design and manufacturing information, GSPR compliance, clinical evaluation, and labeling.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Technical documentation is the evidence package demonstrating conformity—device description, design/manufacture, GSPR, benefit-risk, clinical evaluation, PMS, and labeling under EU MDR Annex II/III (and analogs elsewhere).
PROCESS / STEPS
- Structure docs per market templates (MDR Annex II/III, FDA submissions, etc.).
- Control versions and design history links.
- Ensure traceability from requirements to V&V.
- Keep NB/authority-ready access via EC REP/DMAL/MAH as applicable.
EXAMPLES
- A CER, risk file, and design dossier are core TD elements for implantable devices.
RELATED GUIDES & TOOLS
SOURCES
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